Method of manufacture of a toothpaste composition

ABSTRACT

A method of preparing a toothpaste composition by the steps of adding calcium phosphate in an amount of 0.5 to 5% by weight of the composition and sodium perborate in an amount of 0.5 to 5% by weight of the composition to hot water to form a first mixture and agitating the first mixture, adding to the first mixture sorbitol in an amount of 1 to 50% by weight of the composition, cornstarch in an amount of 0.5 to 10% by weight of the composition and aluminum hydroxide in an amount of 0.01 to 1% by weight of the composition to form a second mixture and agitating the second mixture, adding to the second mixture dicalcium phosphate in an amount of 1 to 50% by weight of the composition and sodium monofluoride phosphate in an amount of 0.7 to 0.8% by weight of the composition to form a third mixture and agitating the third mixture, adding to the third mixture sodium bicarbonate, in an amount of 1 to 50% by weight of the composition, gradually adding increments of a flavoring material in an amount of 0.05 to 2% to control any foaming and to facilitate release of gases to form a fourth mixture, and adding to the fourth mixture sodium lauryl sulfoacetate in an amount of 0.1 to 5% and gum in an amount of 0.5 to 5% and agitating the fourth mixture until a homogeneous paste composition is obtained.

This is a division of application Ser. No. 706,001 filed Feb. 27, 1985,now U.S. Pat. No. 4,603,045.

FIELD OF THE INVENTION

The invention relates to a toothpaste composition and its method ofpreparation particularly where such composition is adapted not only forcleaning natural teeth, but composite filling material as well and whichcontains substances for preventing tooth decay.

BACKGROUND

In filling cavities from which dental caries have been removed, it hasbecome an increasing practice to employ composite filling material whichis similar in color to that of natural tooth material.

Such composite filling material is generally composed of a resinoussubstance which is polymerized in situ and which provides a hard bearingsurface which has the natural appearance of a normal tooth.

Unfortunately, the composite filling material has inherent porosity andis relatively easily stained.

In a normal mouth, a salivary protein pellicle envelopes the tooth andis subject to plaque accumulation. Oral hygiene dictates the removal ofthe plaque accumulation in order to prevent decay of the tooth structureas well as serious diseases of the gums.

In my earlier U.S. Pat. No. 4,405,599, I disclosed toothpastecomposition which is adapted for cleaning natural teeth and compositefilling material as well.

SUMMARY OF THE INVENTION

An object of the invention is to provide a toothpaste which is adaptedfor cleaning natural teeth as well as bonded composite filling materialwhich contains substances for preventing tooth decay.

A further object of the invention is to provide a toothpaste which isspecifically addressed to the removal of stain from composite fillingmaterial as well as from the tooth itself which contains substances forpreventing tooth decay.

Another object of the invention is to provide a toothpaste compositionwhich will be effective to remove the protein pellicles which normallyenvelope the teeth as well as plaque accumulation and which containssubstances for preventing tooth decay.

Another object of the invention is to provide a method for manufactureof the aforesaid tooth paste composition of the invention.

In order to satisfy the above and further objects of the invention,there is provided a toothpaste according to the invention consistingessentially of the following ingredients in percent, by weight:

    ______________________________________                                        Dicalcium Phosphate, dihydrous                                                                     From 1.0% to 50%                                         Calcium Carbonate    From 1.0% to 50%                                         Sodium Bicarbonate   From 1.0% to 50%                                         Magnesium Carbonate  From 1.0% to 25%                                         Sorbitol 70%         From 1.0% to 50%                                         Corn Starch          From 0.5% to 10%                                         Cellulose Gum        From 0.5% to 5.0%                                        Calcium Peroxide     From 0.5% to 5%                                          Sodium Perborate     From 0.5% to 5%                                          Lathanol LAL (Sodium Lauryl                                                                        From 0.1% to 5%                                          Sulfoacetate)                                                                 Aluminum Hydroxide   From 0.01 to 1%                                          Saccharinate (Sodium Salt)                                                                         From 0.05% to 2%                                         Flavoring material   From 0.05% to 2%                                         Alkylparaben         From 0.05% to 1.0%                                       Sodium Monofluoride Phosphate                                                                      From 0.70% to 0.80%                                      Titanium Dioxide     From 0.1% to 10%                                         Deinonized Water     From 10% to 50%                                          ______________________________________                                    

The flavoring material is preferably composed as follows by weight:

    ______________________________________                                        Menthol crystals   20%                                                        Oil of spearmint NF                                                                              20%                                                        Terpeneless spearmint                                                                            30%                                                        Oil of peppermint  20%                                                        Oil of anise       10%                                                        ______________________________________                                    

In the ingredients which have been listed above for the toothpastecomposition, there are ten active constituents which are present in acarefully balanced combination to achieve the objects of the invention.These consist of Dicalcium Phosphate, Calcium Carbonate, MagnesiumCarbonate, Sodium Bicarbonate, Sorbitol, Cornstarch, Cellulose Gum,Calcium Peroxide, Sodium Perborate and Lathanol LAL. The inventioncovers these ingredients as well as their obvious equivalents.

The dicalcium phosphate, calcium carbonate sodium bicarbonate andmagnesium carbonate are cleaning agents. Additionally, the sodiumbicarbonate is an alkalizer and foaming agent.

The Sorbitol is a humectant.

The cornstarch and cellulose gum are thickening agents.

The calcium peroxide and sodium perborate are oxidizing agents.

The Lathanol is a detergent.

The Aluminum Hydroxide is a PH adjuster and is present in an amount toprovide the composition with a substantially neutral PH.

The Saccharinate and flavoring material are present as taste ingredientsand can be varied according to the desired taste to be provided for thecomposition.

The Alkylparaben is a preservative and includes any of the variousalkylparaben compositions (such as methylparaben, propylparaben) capableof acting as perservative.

The sodium monofluoride phosphate is an active agent which is compatiblein the overall composition and provides topical fluoride for inhibitingtooth decay.

The titanium dioxide is a whitening agent.

The Deionized Water is present in an amount to confer a suitable wetnessfor the composition in accordance to the desired viscosity of thecomposition.

DESCRIPTION OF PREFERRED EMBODIMENTS

One of the most important advances in dentistry in the past twenty-fiveyears has been the development of the composite (tooth colored)restoration. This has revolutionized the profession from an estheticconcept. This coupled with the evolution of light activation with itscapability of controlling setting time and the dentist's ability to etchthe enamel of teeth and thus bond the composite material directly ontothe tooth is known as bonding. Bonding enables the dentist to closespaces between teeth, repair chips in teeth, cover discolorations andreshape abnormally shaped teeth. This coupled with the imminentdevelopment of composites for chewing surfaces of posterior teeth isexpected to make the composite filling material the overwhelmingmaterial of choice in dentistry. However, the composite material for allof its advantages is inherently porous and is subject to staining. Thereare two types of composite filling material:

A. The conventional material which is composed of 76% inorganic fillermaterial, such as quartz or Barium glass and 24% Resin Matrix, such asBIS GMA which is the reactive product of BIS Phenol A and GlycidylMethyl acrylic.

B. Microfill--composed of 35-55% inorganic filler--such as fumed silicaand 45-65% Resin Matrix, generally BIS GMA.

The present invention provides for a toothpaste composition which iscapable of cleaning natural teeth as well as the composite fillingmaterial.

The invention provides a toothpaste composition which will satisfy theabove and which has a specific balance of active ingredients to cleannatural teeth as well as composite filling material. This compositionconsists of the following ingredients, given in percent by weight.

    ______________________________________                                        INGREDIENT              AMOUNT IN %                                           ______________________________________                                        Dicalcium Phosphate     7.5                                                   Calcium Carbonate       5                                                     Sodium Bicarbonate      5                                                     Magnesium Carbonate     1.25                                                  Sorbitol 70%            20                                                    Cornstarch              1.3                                                   Cellulose Gum           4.0                                                   Calcium Peroxide        2.4                                                   Sodium Perborate        1.5                                                   Lathanol LAL (Sodium Lauryl Sulfoacetate)                                                             0.7                                                   Aluminum Hydroxide      0.1                                                   Saccharinate (Sodium Salt)                                                                            0.5                                                   Flavoring Material      1                                                     Consisting of:                                                                Menthol crystals                                                                            20%                                                             0.1 of Spearment NF                                                                         20%                                                             Terpeneless Spearmint                                                                       30%                                                             Oil of Peppermint                                                                           20%                                                             Oil of Anise (imitation)                                                                    10%                                                             Methylparaben           0.5                                                   (Hydroxybenzoic acid methyl ester)                                            Propylparaben           0.03                                                  (Hydroxybenzoic acid propylester)                                             Sodium Monofluoride Phosphate                                                                         0.76                                                  Titanium Dioxide        1.0                                                   Deionized Water (to make up 100%)                                                                     47.46                                                 ______________________________________                                    

The above composition had the paste-like texture of standard toothpasteand was found to be exceptionally effective in its ability to removestains and plaque from normal teeth as well as composite fillingmaterial. The sodium monofluoride phosphate is compatible with theremainder of the ingredients and is active to provide a topical fluoridecomposition on the teeth and the composite filling material to inhibitdecay.

It has been found that in order to prepare the toothpaste compositionand retain the activity of the sodium monofluoride phosphate, thecomposition must be prepared as set forth in the following example.

EXAMPLE

The required amount of water was heated to 150° F. and was added to aHobart mixer whose agitation means was activated.

The calcium peroxide and sodium perborate were added to the hot waterand agitation was continued for ten minutes.

The sorbitol, methylparaben (or propylparaben or mixtures thereof),cornstarch and aluminum hydroxide were then added and agitation wascontinued for an additional ten minutes.

Thereafter the dicalcium phosphate, calcium carbonate, magnesiumcarbonate and sodium monofluoride phosphate were added and agitation wascontinued for another ten minutes.

Thereafter the sodium bicarbonate was added gradually and if there isany foaming which takes place and persists, increments of the flavoringmaterial are added to control the foam and facilitate the release ofgases.

The titanium dioxide and saccharinate were then added and agitation wascontinued for at least half an hour.

Finally, the Lathonol and the cellulose gum were added and agitation wascontinued until a homogeneous mass was obtained.

It was found that the homogeneous mass was of suitable paste-likecomposition for use as the toothpaste composition of the invention.

While the invention has been described in connection with specificembodiments thereof, it will become apparent to those skilled in the artthat various equivalents may be used within the scope and spirit of theinvention as defined by the attached claims.

What is claimed is:
 1. A method of preparing a toothpaste compositioncomprising adding calcium phosphate in an amount of 0.5 to 5% by weightof the composition and sodium perborate in an amount of 0.5 to 5% byweight of the composition to hot water to form a first mixture andagitating the first mixture, adding to said first mixture sorbitol in anamount of 1 to 50% by weight of the composition, cornstarch in an amountof 0.5 to 10% by weight of the composition and aluminum hydroxide in anamount of 0.01 to 1% by weight of the composition to form a secondmixture and agitating the second mixture, adding to said second mixturedicalcium phosphate in an amount of 1 to 50% by weight of thecomposition and sodium monofluoride phosphate in an amount of 0.7 to0.8% by weight of the composition to form a third mixture and agitatingthe third mixture, adding to the third mixture sodium bicarbonate, in anamount of 1 to 50% by weight of the composition, gradually addingincrements of a flavoring material in an amount of 0.05 to 2% to controlany foaming and to facilitate release of gases to form a fourth mixture,and adding to the fourth mixture sodium lauryl sulfoacetate in an amountof 0.1 to 5% and gum in an amount of 0.5 to 5% and agitating the fourthmixture until a homogeneous paste composition is obtained.
 2. A methodas claimed in claim 1 wherein the water is initially heated to 150° F.3. A method as claimed in claim 2 wherein the first, second and thirdmixtures are each agitated for ten minutes.
 4. A method as claimed inclaim 2 comprising adding an alkylparaben in an amount of 0.05 to 1.0%by weight of the composition to the second mixture before agitationthereof.
 5. A method as claimed in claim 2 comprising adding calciumcarbonate in an amount of 1 to 50% by weight of the composition andmagnesium carbonate in an amount of 1 to 25% by weight of thecomposition to the third mixture before agitation thereof.
 6. A methodas claimed in claim 2 comprising adding to the fourth mixture titaniumdioxide as a whitening agent in an amount of 0.1 to 10% by weight of thecomposition and saccharinate in an amount of from 0.05 to 2% by weightof the composition and the resulting mixture is agitated for at leastone half hour.
 7. A method as claimed in claim 2 comprising adding acellulose gum in an amount of 0.5 to 5% by weight of the composition tothe fourth mixture before agitation thereof.